MitraClip Approved in US for Otherwise Inoperable Patients

Remember the coverage of Abbott’s MitraClip® device earlier this year? It’s all here. Back in March things were looking a little up in the air as the FDA’s circulatory devices panel gave the clever device its thumbs up, despite the FDA’s summary document at the time saying there were still concerns.

Seven months on, Abbott has now announced that its first-in-class, catheter-based MitraClip® device has received its US approval and will launch immediately in the United States.

Background

MitraClip is designed to repair the mitral valve without the need for an invasive surgical procedure. The device is delivered to the heart through the femoral vein, and effectively secures diseased valve leaflets in a way that minimises valvular leakage. Once implanted, this means the heart is able to pump blood more efficiently, thereby relieving symptoms and improving patient quality of life.

This approval sees MitraClip indicated for patients with significant symptomatic degenerative Mitral Regurgitation (MR) who are at prohibitive risk for mitral valve surgery. To clarify what is meant by prohibitive risk, this is defined as being determined by the clinical judgment of a heart team due to the presence of one or more documented surgical risk factors.

According to a news release from Abbott, multiple trials, published reports, and registries of patients treated with the MitraClip device consistently demonstrate a positive safety profile, reduction in mitral regurgitation, improvement in symptoms, and reduction in hospitalizations for heart failure, even in some of the most ill and debilitated patients. More than 11,000 patients in more than 30 countries have been treated with the MitraClip device, which already has CE mark approval.

Physician comments

“As cardiac surgeons, we see patients with severe mitral regurgitation who we can technically operate on but who are just too frail or sick to survive mitral valve surgery with a reasonable risk and quality of life,” said Michael Mack, M.D., director of Cardiovascular Research and Cardiovascular Medicine and director of Cardiovascular Surgery at Baylor Health Care System in Dallas. “With the MitraClip system, heart teams now have a catheter-based, less-invasive treatment option that can help patients who cannot withstand surgery regain their quality of life.”

“MitraClip is a breakthrough in the treatment of severe mitral regurgitation, a condition that is progressive and causes extreme fatigue and shortness of breath, eventually making even simple tasks virtually impossible, and increasing the risk of stroke, heart failure and death,” said Ted Feldman, M.D., FSCAI, director, Cardiac Catheterization Laboratory and The Mr. and Mrs. Charles R. Walgreen Chair in Interventional Cardiology, NorthShore University HealthSystem, Evanston, Ill. “Clinical data and real-world international experience, dating back to 2003, have consistently shown that the MitraClip is a safe and effective therapy for patients unable to undergo mitral valve surgery, providing meaningful improvements in quality of life that are sustained over time. It has allowed many of my patients to go from bed rest to a more active lifestyle shortly following treatment.”

Company comments

“FDA approval of MitraClip marks an important milestone for Abbott as we continue to bring forward innovative therapies to help patients live better lives,” said Chuck Foltz, senior vice president, vascular, Abbott. “We look forward to making this technology available to specialized centers in the U.S. with multi-disciplinary teams experienced in the management of patients with heart valve disease, a model that facilitates dialogue across physician specialties and provides patients with the best treatment outcomes.”